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CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
Antimicrobial resistance (AMR) can potentially harm global public health. Horizontal gene transfer (HGT), which speeds up ...
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the managem...
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Erectile dysfunction (ED) is a common clinical condition that mainly affects men aged over 40 years. Various causes contri...
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to Augu...
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
The remarkable advance in gene editing technology presents unparalleled opportunities for transforming medicine and findin...
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with t...
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System
Anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAbs) have recently been approved for the prevention...
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriati...
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Gene therapy for many diseases is rapidly becoming a reality, as demonstrated by the recent approval of various nucleic ac...
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
The last decade (2013–2023) has seen unprecedented successes in the clinical translation of therapeutic antisense ol...
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases. Their high specificity to targe...
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International ...
Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?
Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?
We previously proposed that sacituzumab govitecan (SG, Trodelvy®) likely acts as a simple prodrug of systemic SN-38 a...
Unveiling the Biosimilar Paradox of Oncologists’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study
Unveiling the Biosimilar Paradox of Oncologists’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study
Biosimilars offer a cost-effective alternative to original biopharmaceuticals with comparable efficacy and safety. The per...
Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study
Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study
Serplulimab is a novel, recombinant, humanized, monoclonal, anti-programmed death 1 antibody with a similar or better affi...
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
QX006N is a novel, humanized, IgG4κ monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lup...
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and ...
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of ...
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
CT-P43 is a candidate ustekinumab biosimilar in clinical development. This paper aims to demonstrate equivalent efficacy o...
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. ...
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medi...
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiat...
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
AAV-Based Strategies for Treatment of Retinal and Choroidal Vascular Diseases: Advances in Age-Related Macular Degeneration and Diabetic Retinopathy Therapies
Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are vascular diseases with high prevalence, ranking a...
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval...
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access
In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration mar...
Outer Membrane Vesicle Vaccine Platforms
Outer Membrane Vesicle Vaccine Platforms
Outer membrane vesicles (OMVs) are spontaneously released by many gram-negative bacteria during their growth and constitut...
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
Immunotherapy Guided by Immunohistochemistry PD-L1 Testing for Patients with NSCLC: A Microsimulation Model-Based Effectiveness and Cost-Effectiveness Analysis
On the basis of immunohistochemistry PD-L1 testing results, patients with advanced non-small cell lung cancer (NSCLC) are ...
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axia...
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer
Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on th...
Malaria Vaccines: Progress to Date
Malaria Vaccines: Progress to Date
Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium. Despite significant declines in...
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